SeaSpine Cabo ACP (Anterior Cervical Plate) System
FDA 510(k) K173521 · SeaSpine Orthopedics Corporation
510(k) numberK173521
Submission
- Device name
- SeaSpine Cabo ACP (Anterior Cervical Plate) System
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- November 14, 2017
- Decision date
- January 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | 07/01/2026SE |
| K250908 | Virata Spinal Fixation SystemNKB · Traditional | 06/18/2025SE |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsOLO · Traditional | 04/02/2025SE |
| K242273 | Cove Putty, OsteoCove PuttyMQV · Traditional | 09/25/2024SE |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…MAX · Special | 06/20/2024SE |
| K240566 | Reef L Interbody System; WaveForm L Interbody SystemMAX · Traditional | 04/26/2024SE |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…NKB · Traditional | 04/19/2024SE |
| K233694 | Meridian Interbody System; WaveForm A Interbody SystemMAX · Traditional | 01/12/2024SE |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody SystemOVE · Traditional | 11/28/2023SE |
| K232668 | Cove Strip, OsteoCove StripMQV · Special | 09/27/2023SE |
Questions and answers
When was SeaSpine Cabo ACP (Anterior Cervical Plate) System cleared by the FDA?
SeaSpine Cabo ACP (Anterior Cervical Plate) System (K173521) received a 510(k) decision of Substantially Equivalent on January 24, 2018, 71 days after the submission was received.
What is the product code of K173521?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.